Refractive Errors
Conditions
Keywords
Contact Lens, Daily Wear, Vision Correction
Brief summary
The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.
Detailed description
Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.
Interventions
DEVICELID015385 contact lenses
Investigational silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
DEVICECLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting system
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. * Manifest cylinder ≤ 0.75 diopter (D) in each eye. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * Monovision contact lens wearers. * Habitually wearing Biofinity® lenses. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit) | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned. |
| Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit) | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 8 investigative sites located in the United States.
Pre-assignment details
Of the 120 subjects enrolled, 1 was exited from the study prior to randomization as a screen failure. This reporting group includes all enrolled and dispensed subjects (119).
Participants by arm
| Arm | Count |
|---|---|
| Biofinity Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE. | 41 |
| LID015385 LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE. | 78 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Corneal cylinder greater than 1.00 diopter | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Biofinity | Total | LID015385 |
|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 7.7 | 32.4 years STANDARD_DEVIATION 7.7 | 32.9 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 114 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 39 Participants | 106 Participants | 67 Participants |
| Region of Enrollment United States | 41 participants | 119 participants | 78 participants |
| Sex: Female, Male Female | 28 Participants | 91 Participants | 63 Participants |
| Sex: Female, Male Male | 13 Participants | 28 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 82 | 0 / 41 | 0 / 156 | 0 / 78 |
| other Total, other adverse events | 0 / 119 | 0 / 82 | 0 / 41 | 0 / 156 | 0 / 78 |
| serious Total, serious adverse events | 0 / 119 | 1 / 82 | 0 / 41 | 0 / 156 | 0 / 78 |
Outcome results
Primary
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)
Population: This analysis population includes all enrolled and dispensed subjects/eyes that completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Day 1 Dispense | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Week 1 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Week 2 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 1 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 2 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 3 Follow-up/Exit | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 2 Follow-up | -0.04 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Day 1 Dispense | -0.06 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 1 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Week 1 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Month 3 Follow-up/Exit | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Week 2 Follow-up | -0.06 logMAR | Standard Deviation 0.06 |
Primary
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Population: This analysis population includes all enrolled and dispensed subjects/eyes that discontinued the study early.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Day 1 Dispense | -0.04 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Week 1 Follow-up | -0.02 logMAR | Standard Deviation 0.05 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Week 2 Follow-up | -0.04 logMAR | Standard Deviation 0.06 |
| Biofinity | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 1 Follow-up | 0.00 logMAR | Standard Deviation 0 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 1 Follow-up | -0.12 logMAR | Standard Deviation 0 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Week 2 Follow-up | -0.05 logMAR | Standard Deviation 0.06 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Day 1 Dispense | -0.06 logMAR | Standard Deviation 0.07 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Month 2 Follow-up | -0.12 logMAR | Standard Deviation 0 |
| LID015385 | Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Week 1 Follow-up | -0.06 logMAR | Standard Deviation 0.07 |